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EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
48
Feed Risk assessment of the chain of soya (bean) meal and oil products
(4.1)
Productionof refined
soya (bean) oil
(4.2)
Production of soy fatty
acid distillates
(4.3)
Production of soy acid
oils
(4.4)
Production of soy deo- distillates
(4) Refining
Filter
aids
Soap
stocks Used bleaching
earth
(3) Crushing of soya (beans)
Hulls
(3.2) Production of crude lecithins (gums)
(3.1) Production of crude oil
(3.3) Production of soya (bean) meal
Soy acid oils
Refined soya
(bean) oil
Soya (bean) hulls
(A) Transport EU FEED INDUSTRY
INSIDE EU
(B) Transport
Crude lecithins
(3.4) Separation of soya (bean) hulls Crude degummed
soya (bean) oil
Soya (bean) meal
(B) Transport
Blending (C) Storage
(B) Transport
(C) Storage
(B) Transport (C) Storage
(Sem
i
batc
h
refin
ing)
Soy deo
distillates
Soy fatty acid
distillates
(Sem
i bat
ch
refin
ing)
(D) Transport by
ocean going
vessel
OUTSIDE EU
Flow chart of the production chain of soya (bean) meal and oil products for feed application in the EU
Crushing of soya (beans)
Hulls Production of crude lecithins (gums)
Production of crude oil
Production of soya (bean) meal
(1) Cultivation of soya (beans)
Soya (beans)
Dried soya (beans)
(A) Transport Storage
(2) Drying at primary production
Crude lecithins
Separation of soya (bean) hulls
Characters between brackets refer to those on the following sheets
Production of refined soya
(bean) oil
Production of soy fatty acid
distillates
Production of soy acid
oils
Production of soy deo- distillates
Refining Soy deo distillates
Soy fatty acid
distillates
Soya acid oils
Refined soya
(bean) oil
Used bleaching earth Filter aids
Soap stocks
(B)Transport
Storage
Crude degummed
soya (bean)oil
Soya (bean) meal
distillates Soya (bean) hulls
(B) Transport
(A) Transport Storage
(D) Transport by ocean
going vessel
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
49
Feed Risk assessment of the chain of soya (bean) meal and oil products
6. Risk assessment of the chain of soybean meal and oil products
1. Cultivation of soya (beans)*
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C The countries of export of soya (beans)
(USA, Brazil, Argentina and Paraguay)
work with positive lists for the use of
pesticides during cultivation which, for
some substances, may conflict with
European pesticide residue legislation.
Regular monitoring of pesticides on soya
(beans) shows that residue levels remain
within legal limits.
EC Regulation 396/2005
prohibits putting into
circulation commodities that
do not comply with the MRLs
set in the annexes. EC
Regulation No. 178/2006
establishes Annex I that lists
the food and feed products for
which pesticide residue limits
apply. Regulation 149/2008
establishes Annexes II, III and
IV that sets the MRLs for the
products listed in Annex I.
Non-EU-authorised GMOs B Different pace of approval of new GMOs
between EU and third countries from
which oilseeds are imported. Risk of
traces of non-EU-authorised GMOs
ending up in EU imported oilseeds.
This is an issue of legal
compliance, rather than one
on food safety.
Phytotoxins C Soya (beans) may contain weeds. Directive 2002/32/EC limits
the maximum content of toxic
weed seeds.
Visual inspection of soya
(beans) is recommended as a
control measure.
* Assessment of risks outside the EU is out of the scope of this document. See Methodology document paragraph 2.3 for more information.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
50
Feed Risk assessment of the chain of soya (bean) meal and oil products
2. Drying of soya (beans) at primary production*
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR CONTRACT
TERMS
CONTROL MEASURE REMARKS
Contaminants caused by
drying
- dioxin C Burning of waste may result in
dioxin formation. Up to now
the crushers have found
dioxin levels in crude soya
(bean) oil to be lower than
detection limit.
Code of Practice for the
prevention and reduction of
dioxin and dioxin-like PCB
contamination in foods and
feeds (Codex CAC/RCP 62-
2006).
Good Manufacturing Practices recommend using fuels which are not generating dioxins and dioxin-like compounds and other harmful contaminants.
In case of direct heating, proper burners should be used. Monitoring is regarded necessary to ensure that drying or heating processes do not result in elevated levels of dioxins and dioxin-like PCBs. No use of waste products as a fuel for direct drying.
Feed materials derived from
soya (beans) have to comply with the
limits for dioxin and dioxin-like PCBs
of the Directive 2002/32/EC.
* Assessment of risks outside the EU is out of the scope of this document. See Methodology document, paragraph 2.3 for more information.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
51
Feed Risk assessment of the chain of soya (bean) meal and oil products
Utilities: soya (beans) crushing, oil refining and processing
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Hydraulic oils or lubricants
from equipment
C Low High 3 Hydraulic oils and lubricants may contain
toxic compounds.
The prerequisite programme
should assure that the
contamination of product with
non-food grade hydraulic oils
or lubricants is avoided and
that the risk of contamination
of the product with food grade
hydraulic oils and lubricants is
minimised. The prerequisite
programme could involve
recording of the quantities
used.
Contaminants in water
such as PFOS and PFOA
C Low Medium 2 Water is used in the crushing and refining
process.
For manufacture of feed,
according to Regulation
183/2005/EC water used
shall be of suitable quality.
Cleaning agents and boiler
chemicals
C Medium Medium 3 Cleaning agents and steam (using boiler
chemicals) come into contact with the
product.
Cleaning agents used in the
production system should be
flushed. Cleaning agents and
boiler chemicals must be
suitable for use in the food
industry.
Thermal heating fluids
(THF) from equipment
C Medium High 4 THF may still be used by non-FEDIOL
members.
According to the FEDIOL
Code of Practice on the
Heating of Edible Oils during
Processing, the use of THF is
not allowed.
Use hot water or steam
heating. Otherwise, a control
measure should assure that
the contamination of product
with thermal heating fluids is
avoided.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
52
Feed Risk assessment of the chain of soya (bean) meal and oil products
3. Crushing of soya (beans)
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Toxins from pest control
materials
C Low High 3 Poisoned grain from open boxes could
end up in the food chain.
A pest control programme
must be applied that is
suitable for use in the food
chain.
Toxic compounds from
hexane such as benzene
C Low High 3 Industrial hexane may contain toxic
compounds.
Directive 2009/32/EC sets
purity criteria for the use of
hexane during the crush of
oilseeds.
Food grade hexane must be
used.
Foreign material like glass,
wood, metals, etc.
P Medium Medium 3 Foreign material may be present. A system should be in place
that removes foreign material.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
53
Feed Risk assessment of the chain of soya (bean) meal and oil products
3.1 Production of crude oil
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Contaminants from filter
aids
C Low High 3 The crude oil can potentially wash
contaminants out of the filter aid.
Use of filter aids that are
suitable for the food industry.
Mineral oils from a failing
recovery system
C Medium Medium 3 Food grade low-medium viscosity mineral
oils are used for hexane recovery. It is in
the interest of the crusher to recover as
much hexane as possible, and to thus
maintain the recovery system well.
Mineral oil of the recovery
system must be of food grade
quality. The prerequisite
programme should assure
that the contamination of
product with non-food grade
oils is avoided and that the
risk of contamination of the
product with food grade oils is
minimised. The prerequisite
programme could involve
recording of the quantities
used.
The Dutch GMP-limit for
C (10-40) in oils is 400
mg/kg.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C Low* Medium 2 Regular monitoring of pesticide residues
on soya (beans) shows that residue levels
remain within legal limits.
Regulation 396/2005 sets
limits for residues of
pesticides. This regulation
allows using a processing/
concentration factor for
pesticides into processed
products, providing food
safety is assured.
The FEDIOL position
(11SAF181) concludes that
based on the average oil
content in soybeans ranging
from 18%-21%, a processing
factor of 5 should be used to
*Certain origins of
soybeans can have a
medium chance of
exceeding the MRL for
particular pesticide
residues.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
54
Feed Risk assessment of the chain of soya (bean) meal and oil products
establish the MRL in soybean
oil.
Pesticides residues as
listed in EU Directive
2002/32 for undesirable
substances in feeding stuff
C very low High 2 Some of the banned pesticides may be
present in the environment. The chance of
finding them in crude soya (bean) oil,
however, is very low. The use of
endosulfan is allowed on soya (beans).
Monitoring data show that its residue in
crude oil remains within the legal limit.
Directive 2002/32/EC sets
limits for a number of
pesticides residues in feeding
stuff.
Hexane that resides in the
crude oil after recovery
C High little 3 After hexane extraction of the oil and
subsequent hexane recovery from the oil,
traces of hexane will reside in the crude
oil.
Feed Marketing Regulation
767/2009 stipulates that feed
materials shall be free from
chemical impurities resulting
from the manufacturing
process and from processing
aids, unless a maximum
content is fixed in the
Catalogue. The Catalogue of
Feed Materials, Regulation
68/2013 introduces a
threshold for the setting of
max contents for these
chemical impurities of 0.1%
(1000 ppm).
Toxicological
assessments show that
crude soya oil with
hexane levels of up to
1000 ppm is feed safe.
FOSFA has a flash point
limit at 121 ̊C, which is
related to transport and
storage safety.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
55
Feed Risk assessment of the chain of soya (bean) meal and oil products
3.2 Production of crude lecithins
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Mineral oils from a failing
recovery system
C Medium Medium 3 Food grade low-medium viscosity mineral
oils are used for hexane recovery. It is in
the interest of the crusher to recover as
much hexane as possible, and to thus
maintain the recovery system well.
Mineral oil of the recovery
system must be of food grade
quality. The prerequisite
programme should assure
that the contamination of
product with non-food grade
oils is avoided and that the
risk of contamination of the
product with food grade oils is
minimised. The prerequisite
programme could involve
recording of the quantities
used.
The Dutch GMP-limit for
C (10-40) in oils is 400
mg/kg.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C Low* Medium 2 Regular monitoring of pesticide residues
on soya (beans) shows that residue levels
may exceed legal limits.
Regulation 396/2005 sets
limits for residues of
pesticides. This regulation
allows using a processing/
concentration factor for
pesticides into processed
products, providing food
safety is assured.
Check incoming soybeans or
the crude lecithins. In case of
a pesticide residue level
exceeding the limit, a feed
safety assessment should be
carried out.
*Certain origins of
soybeans can have a
medium chance of
exceeding the MRL for
particular pesticide
residues.
Pesticides residues as
listed in EU Directive
2002/32 for undesirable
substances in feeding stuff
C very low High 2 Some of the banned pesticides may be
present in the environment. The chance of
finding them in crude soya (bean) oil,
however, is very low. The use of
endosulfan is allowed on soya (beans).
Monitoring data show that its residue in
crude oil remains within the legal limit.
Directive 2002/32/EC sets
limits for a number of
pesticides residues in feeding
stuff.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
56
Feed Risk assessment of the chain of soya (bean) meal and oil products
Hexane that resides in the
crude lecithins after
recovery
C High little 3 After hexane extraction of the oil and
subsequent hexane recovery from the oil,
traces of hexane will reside in the crude
oil.
Feed Marketing Regulation
767/2009 stipulates that feed
materials shall be free from
chemical impurities resulting
from the manufacturing
process and from processing
aids, unless a maximum
content is fixed in the
Catalogue. The Catalogue of
Feed Materials, Regulation
68/2013 introduces a
threshold for the setting of
max contents for these
chemical impurities of 0.1%
(1000 ppm).
Toxicological
assessments show that
feed materials with
hexane levels of up to
1000 ppm are feed safe.
FOSFA has a flash point
limit at 121 ̊C, which is
related to transport and
storage safety.
Pathogens B Low Medium 2 Microbiological growth as a result of
condensation of water evaporated from
the wet gums.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
57
Feed Risk assessment of the chain of soya (bean) meal and oil products
3.3 Production of soya (bean) expeller and meal
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Dioxin from anti-caking
agent
C Low High 3 Anti-caking agent is of mineral origin and
may contain dioxin by nature. Dioxin is
toxic to humans and animals.
Regulation 2439/1999/EC
sets quality criteria for anti-
caking agents.
Purchase anti-caking agent of
feed grade quality.
Salmonella B High High 4 Salmonella is the major hazard for
microbiological contamination of feed.
Salmonella are widespread in the
environment and each link in the food
chain, from the producers up to and
including the consumers has a role to play
in reducing the risk of Salmonella harming
animals or humans. FEDIOL together with
three other associations representing the
suppliers and consumers of feed, ie
FEFAC, COCERAL and COPA-COGECA
have accepted responsibility for issuing
guidance for industry to help it control
Salmonella and have published the
“Common principles for the management
of the Salmonella risk in the feed chain” in
June 2011. The European Guide to good
practice for the industrial manufacture of
safe feed materials has been amended so
as to comply with these principles.
FEDIOL, FEFAC, COCERAL,
COPA-COGECA Common
principles for the
management of the
Salmonella risk in the feed
chain.
The operator’s PRP
programme is to cover the
following measures:
a) Preserving feed materials
from contamination during
processing and storage eg by
closed systems, hygiene
practices, or by separating the
premises into hygienic zones
as appropriate.
b) Applying time and
temperature control on the
Desolventiser Toaster (DT).
c) Apply moisture control of
the meals/expellers
If the monitoring system
indicates that Salmonella is
found in the finished feed
material, the following actions
shall be considered:
o Carry out serotyping and traceability to
The operator shall
introduce line monitoring
with samples to be taken
from the whole line, from
where the product leaves
the DT, from when it
enters the storage silo up
to and including the load
out area.
The operator is to set
realistic targets for
reduction of the
incidence of Salmonella
contamination of his
meals/expellers basis
historic data.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
58
Feed Risk assessment of the chain of soya (bean) meal and oil products
identify the source of contamination; o Review processing conditions and relevant pre-requisite programs o Additional cleaning of storage and vehicles (where appropriate); o Additional cleaning of plant and equipment; o Review previous monitoring results o Consider additional training or changes in process or procedures o Applying chemical treatment with the aim to reduce Salmonella to acceptable levels.
Dioxin from used bleaching
earth
C Low High 3 Bleaching clay is of mineral origin and
may contain dioxin by nature. Dioxin is
toxic to humans and animals.
Directive 2002/32/EC limits
the dioxin content in feed
material of vegetable origin to
0.75 ng/kg (WHO-PCDD/F-
TEQ) and limits the sum of
dioxin and dioxin-like PCBs to
1,5 ng/kg (WHO-PCDD/F-
PCB-TEQ).
FEDIOL has developed a
Code of Practice on the
purchase conditions of fresh
bleaching earth for oil refining,
which includes a maximum
limit for dioxin and dioxin-like
PCBs of 1,5 ng/kg (WHO-
PCDD/F-PCB-TEQ) as
upperbound value.
Purchase fresh bleaching
earth from suppliers that fulfil
the FEDIOL specifications as
listed in the FEDIOL Code of
Practice on the purchase
conditions of fresh bleaching
earth for oil refining.
The risk only applies to
integrated crushing and
refining plants.
Hexane residue C High little 3 Hexane residue is present in oilseed
meals.
Feed Marketing Regulation
767/2009 stipulates that feed
materials shall be free from
Toxicological
assessments show that
oilseed meals with
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
59
Feed Risk assessment of the chain of soya (bean) meal and oil products
chemical impurities resulting
from the manufacturing
process and from processing
aids, unless a maximum
content is fixed in the
Catalogue. The Catalogue of
Feed Materials, Regulation
68/2013 introduces a
threshold for the setting of
max contents for these
chemical impurities of 0.1%
(1000 ppm).
hexane levels of up to
1000 ppm are feed safe.
Germany has contractual
specifications of max 300
ppm hexane in soybean
meal for explosion
prevention during barge
transport.
Cadmium C Low Medium 2 Depending on origin soybeans can contain
elevated levels of Cd as a result of
fertiliser basis Cd contaminated
phosphorus.
This risk is applying to
certain geographical
origins.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
60
Feed Risk assessment of the chain of soya (bean) meal and oil products
3.4 Separation of soya (bean) hulls
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Salmonella B High High 4 Salmonella is the major hazard for
microbiological contamination of feed.
Salmonella are widespread in the
environment and each link in the food
chain, from the producers up to and
including the consumers has a role to play
in reducing the risk of Salmonella harming
animals or humans. FEDIOL together with
three other associations representing the
suppliers and consumers of feed, ie
FEFAC, COCERAL and COPA-COGECA
have taken their responsibility and have
published the “Common principles for the
management of the Salmonella risk in the
feed chain” in June 2011. The European
Guide to good practice for the industrial
manufacture of safe feed materials has
been amended so as to comply with these
principles.
FEDIOL, FEFAC, COCERAL,
COPA-COGECA Common
principles for the
management of the
Salmonella risk in the feed
chain.
.
The operator’s PRP
programme is to cover the
following measures:
a) Preserving feed materials
from contamination during
processing and storage eg by
closed systems, hygiene
practices, or by separating the
premises into hygienic zones
as appropriate.
b) Apply moisture control
If the monitoring system
indicates that Salmonella is
found in the finished feed
material, the following actions
shall be considered:
o Carry out serotyping and traceability to identify the source of contamination; o Review processing conditions and relevant pre-requisite programs o Additional cleaning of storage and vehicles (where appropriate); o Additional cleaning of plant and equipment;
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
61
Feed Risk assessment of the chain of soya (bean) meal and oil products
o Review previous monitoring results o Consider additional training or changes in process or procedures o Applying chemical treatment with the aim to reduce Salmonella to acceptable levels.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C Low* Medium 2 Regular monitoring of pesticide residues
on soybeans shows that residue levels
remain within legal limits.
MRL policy in third countries differs from
EU MRL policy.
EC Regulation No. 396/2005 sets
limits for residues of pesticides.
FEDIOL contract for purchasing
sun seeds form the Black Sea
area (contains a clause on
compliance with EU MRL
legislation).
*Certain origins of
soybeans can have a
medium chance of
exceeding the MRL for
particular pesticide
residues.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
62
Feed Risk assessment of the chain of soya (bean) meal and oil products
4. Refining
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Contaminants in
Processing aids
(alkali solution, acids) such
as mercury in caustic soda.
C Low High 3 Processing aids come into contact with the
product.
Processing aids that directly
come into contact with the oil
must be for food use or of
food grade quality.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
63
Feed Risk assessment of the chain of soya (bean) meal and oil products
4.1 Production of refined soya (bean) oil
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY STANDARDS AND/OR
CONTRACT TERMS CONTROL MEASURE REMARKS
Dioxin and dioxin-like PCBs C Low High 3 A potential source of dioxin contamination
for the oil is drying of soybeans and
bleaching earth. However, the dosage
level of bleaching earth during refining is
only 1-3%. Dioxin partly evaporates during
distillation.
Directive 2002/32/EC limits the dioxin content
in feed material of vegetable origin to 0.75
ng/kg (WHO-PCDD/F-TEQ) and limits the
sum of dioxin and dioxin-like PCBs to
1,5 ng/kg (WHO-PCDD/F-PCB-TEQ).
FEDIOL has developed a Code of Practice on
the purchase conditions of fresh bleaching
earth for oil refining, which includes a
maximum limit for dioxin and dioxin-like PCBs
of 1,5 ng/kg (WHO-PCDD/F-PCB-TEQ) as
upperbound value.
Purchase fresh
bleaching earth from
suppliers that fulfil the
FEDIOL specifications
as listed in the FEDIOL
Code of Practice on the
purchase conditions of
fresh bleaching earth
for oil refining.
CB: If during
the revision of
the FBE code,
that code is
only going
apply for
integrated
crushing, and
hence not for
stand-alone
refining, then
the reference to
bleaching earth
being a source
for dioxin
contamination
should be
deleted from
the justification
column.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C Low* Medium 2 Regular monitoring of pesticide residues
on soya (beans) shows that residue levels
may exceed legal limits. However, the
experience is that pesticide residues are
removed during refining.
Regulation 396/2005 sets limits for residues
of pesticides. This regulation allows using a
processing/concentration factor for
pesticides into processed products, providing
feed safety is assured.
The FEDIOL position (11SAF181) concludes
that based on the average oil content in
soybeans ranging from 18%-21%, a
processing factor of 5 should be used to
establish the MRL in soybean oil.
*Certain origins
of soybeans
can have a
medium chance
of exceeding
the MRL for
particular
pesticide
residues.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
64
Feed Risk assessment of the chain of soya (bean) meal and oil products
Pesticides residues as
listed in EU Directive
2002/32 for undesirable
substances in feeding stuff
C very Low High 2 Some of the banned pesticides may be
present in the environment. The chance of
finding them in crude soya (bean) oil,
however, is very low. The use of
endosulfan is allowed on soya (beans).
Monitoring data show that its residue in
crude oil remains within the legal limit.
Directive 2002/32/EC sets limits for a number
of pesticides residues in feeding stuff.
Foreign materials like glass,
wood, metals, etc.
P Medium Medium 3 Foreign materials may be present. Apply hygienic
practices (eg closed
systems). Filter before
loading.
4.2 Physical refining: production of soy fatty acid distillates
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY STANDARDS AND/OR
CONTRACT TERMS CONTROL MEASURE REMARKS
Dioxin C Low High 3 A potential source of dioxin contamination
during refining of the oil is bleaching earth.
However, the dosage level of bleaching
earth during refining is only 1-3%.
Directive 2002/32/EC limits the dioxin content
in feed material of vegetable origin to 0.75
ng/kg (WHO-PCDD/F-TEQ) and limits the
sum of dioxin and dioxin-like PCBs to
1,5 ng/kg (WHO-PCDD/F-PCB-TEQ).
Products intended for animal feed containing
a level of undesirable substance that exceeds
the legal limit may not be mixed for dilution
purposes with the same, or other, products
Purchase fresh
bleaching earth from
suppliers that fulfil the
FEDIOL specifications
as listed in the FEDIOL
Code of Practice on the
purchase conditions of
fresh bleaching earth
for oil refining.
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
65
Feed Risk assessment of the chain of soya (bean) meal and oil products
intended for animal feed (Directive
2002/32/EC).
According to Regulation 225/2012 amending
the Feed Hygiene Regulation 183/2005 100%
of the batches of fatty acid distillates for feed
shall be tested on the sum of dioxins and
dioxin-like PCBs.
FEDIOL has developed a Code of Practice on
the purchase conditions of fresh bleaching
earth for oil refining, which includes a
maximum limit for dioxin and dioxin-like PCBs
of 1,5 ng/kg (WHO-PCDD/F-PCB-TEQ) as
upperbound value.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C Low* Medium 2 Regular monitoring of pesticide residues
on soya (beans) shows that residue levels
may exceed legal limits. During refining
pesticide residues move from the oil to the
fatty acid distillate.
Regulation 396/2005 sets limits for residues
of pesticides. This regulation allows to use a
processing/concentration factor for
pesticides into processed products, providing
feed safety is assured.
Check incoming
soybeans or the fatty
acid distillates. In case
of a pesticide residue
level exceeding the
limit, a feed safety
assessment should be
carried out.
*Certain origins
of soybeans
can have a
medium chance
of exceeding
the MRL for
particular
pesticide
residues.
Pesticides residues as
listed in EU Directive
2002/32 for undesirable
substances in feeding stuff
C Low High 3 Some of the banned pesticides may be
present in the environment. The chance of
finding them in crude soya (bean) oil,
however, is very low. The use of
endosulfan is allowed on soya (beans).
Monitoring data show that its residue in
crude oil remains within the legal limit.
Directive 2002/32/EC sets limits for a number
of pesticides residues in feeding stuff.
Non-complying product
should not be applied to
feeding stuff.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
4.3 Chemical refining: production of soy soap stocks and soy acid oils free from deodistillates
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY STANDARDS AND/OR
CONTRACT TERMS CONTROL MEASURE REMARKS
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C Low Medium 2 Regular monitoring of pesticide residues
on soya (beans) shows that residue levels
remain may exceed limits. Level of
pesticide residues in acid oil will mirror
that in crude oil.
Regulation 396/2005 sets limits for residues
of pesticides. This regulation allows using a
processing/concentration factor for authorised
pesticides into processed products, providing
feed safety is assured.
Check incoming beans
or the soap stock and
acid oil. In case of a
pesticide residue level
exceeding the limit, a
feed safety assessment
should be carried out.
*Certain origins
of soybeans
can have a
medium chance
of exceeding
the MRL for
particular
pesticide
residues.
Pesticides residues as
listed in EU Directive
2002/32 for undesirable
substances in feeding stuff
C very low High 2 Some of the banned pesticides may be
present in the environment. The chance of
finding them in crude soya (bean) oil,
however, is very low. The use of
endosulfan is allowed on soya (beans).
Monitoring data show that its residue in
crude oil remains within the legal limit.
Directive 2002/32/EC sets limits for a number
of pesticides residues in feeding stuff.
Dioxin C Very low High 2 The FEDIOL factsheet on crushing and
refining in relation to soap stock
production (Ref 12SAF183) indicates that
the level of oil soluble contaminants in
soap stocks mirrors that of crude oils.
According to Regulation 225/2012 amending
the Feed Hygiene Regulation 183/2005 100%
of the batches of soap stocks and acid oils for
feed shall be tested on the sum of dioxins
and dioxin-like PCBs.
In integrated
crushing and
refining plants,
soap stocks can
therefore be
safely put back
on the meal.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
4.4 Chemical refining: production of soy deodistillates
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY STANDARDS AND/OR
CONTRACT TERMS CONTROL MEASURE REMARKS
Dioxin C Medium High 4 A potential source of dioxin
contamination during refining of the oil
is bleaching earth. During chemical
refining, dioxins concentrate into the
deodistillates.
Directive 2002/32/EC limits the dioxin content in
feed material of vegetable origin to 0.75 ng/kg
(WHO-PCDD/F-TEQ) and limits the sum of dioxin
and dioxin-like PCBs to 1,5 ng/kg (WHO-PCDD/F-
PCB-TEQ).
According to Regulation 225/2012 amending the
Feed Hygiene Regulation 183/2005 100% of the
batches of deodistillates for feed shall be tested on
the sum of dioxins and dioxin-like PCBs.
Products intended for animal feed containing a level
of undesirable substance that exceeds the legal
limit may not be mixed for dilution purposes with the
same, or other, products intended for animal feed
(Directive 2002/32/EC).
FEDIOL has developed a Code of Practice on the
purchase conditions of fresh bleaching earth for oil
refining, which includes a maximum limit for dioxin
and dioxin-like PCBs of 1,5 ng/kg (WHO-PCDD/F-
PCB-TEQ) as upperbound value.
Deodistillates from chemical
refining are forbidden for use
in feed unless they have been
treated so as to ensure that
dioxin levels are matching
limits of the Undesirable
Substances Directive 2002/32
(see also the FEDIOL
factsheet on treated
deodistillates for use in feed,
Ref 12SAF196).
Fatty products obtained from
batch refining processes
combining physical and
chemical refining steps in one
and the same equipment may
be used for feed purposes,
provided that there is
analytical proof showing that
limits for dioxin and pesticide
residues are respected.
Purchase fresh bleaching
earth from suppliers that fulfil
the FEDIOL specifications as
listed in the FEDIOL Code of
Practice on the purchase
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Feed Risk assessment of the chain of soya (bean) meal and oil products
conditions of fresh bleaching
earth for oil refining.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C High Medium 4 Regular monitoring of pesticide
residues on soya (beans) shows that
residue levels may exceed legal
limits.During chemical refining,
pesticide residues concentrate into the
deodistillates.
Regulation 396/2005 sets limits for residues of
pesticides. This regulation allows using a transfer
factor for authorised pesticides into processed
products, providing feed safety is assured.
Check incoming soybeans or
deodistillate. In case of a
pesticide residue level
exceeding the limit, a feed
safety assessment should be
carried out.
Pesticides residues as
listed in EU Directive
2002/32 for undesirable
substances in feeding stuff
C Medium High 4 Some of the banned pesticides may be
present in the environment. The
chance of finding them in crude soya
(bean) oil, however, is very low. During
refining, endosulfan may partly end up
in the distillate.
Directive 2002/32/EC sets limits for a number of
pesticides residues in feeding stuff.
See above under “general”.
Deodistillates from chemical
refining are forbidden for use
in feed unless they
have been treated so as to
ensure that pesticide residue
levels levels are matching
limits of the Undesirable
Substances Directive 2002/32
(see also the FEDIOL
factsheet on treated
deodistillates for use in feed,
Ref 12SAF196)..
Mineral oil C Medium Medium 3 Mineral oil used as anti dusting agent
will concentrate in the deodistillate
Check incoming soybeans or
deodistillate.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
5. Hydrogenation of soybean oil
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
nickel C Low High 3 Nickel is used as a catalyst with
hydrogenation (hardening) of oil.
Processing aids that directly
come into contact with the oil
must be for food use or of
food grade quality.
Filter the hardened oil.
The nickel content of
hardened oils from
FEDIOL members is well
below 20 ppm.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
A. Storage and transport of soybeans and soybean meal and hulls
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR CONTRACT
TERMS
CONTROL MEASURE REMARKS
Toxins from pest control
materials
C Low High 3 Poisoned grain from open boxes could end up in
the food chain.
A pest control programme
must be applied that is
suitable for use in the food
chain.
Pesticide residues above
the MRL, i.e. residues of
herbicides, insecticides,
fungicides or rodenticides
above the MRL.
C Medium Medium 3 Post-harvest use of pesticides on oilseeds is
critical due to the limited time that is available for
the pesticides to break down. The countries of
export of oilseeds work with positive lists for the
use of pesticides which, for some substances,
may conflict with European legislation,
particularly in the case of soft seeds such as
those of sunflowers.
Regulation 396/2005 prohibits
putting into circulation
commodities that do not comply
with the MRLs set in the annex of
this regulation.
Transport and storage
companies must use
pesticides correctly and
document this. Otherwise
they must verify that the
levels of the residues of
the pesticides used during
transport and storage
comply with EU legislation.
Contamination by the
previous cargo during the
transport by farm cart, truck
or barge or ocean going
vessel
C Low High 3 Transport of oilseeds and oilseed meals usually
does not take place in means of transport that
are dedicated to the transport of food or feed.
Transport companies must
clean farm carts, trucks,
barges and ocean-going-
vessels before loading.
Inspection on cleanliness
before loading.
Contamination by the
previous cargo during
storage
C Low High 3 Oilseeds and oilseed meals may be
contaminated with mycotoxin containing
previous loads.
Storage companies must
clean sites before use and
must inspect them on
cleanliness before use.
Anti dusting agent on soya
(beans)
C Medium Medium 3 For dust prevention, the USA allows the
spraying of white oils (paraffins) on soya (beans)
at levels of up to 200 ppm. In South America
soya (bean) oil is used.
Check incoming soybeans
from the USA.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
Adulteration with melamine C Low Medium 2 Analytically, melamine mimics proteins Regulation 2002/32 sets a limit of
2.5 mg/kg for melamine in feed
materials.
New
B.
Transport of soybean oil and derived products for feed application by
tank car, rail tank, barge or coaster (excluding ocean going vessel).
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Contamination by previous
cargo
- Tank cars, rail tanks and barges
C Medium High 4 Tank cars and barges may have been
used for non food or non feed
compatible products such as
petrochemicals.
Tank cars and barges that are
not dedicated to the transport
of foodstuff or feeding stuff
should have undergone a
validated cleaning procedure.
- Tank cars, tank containers,
rail tanks and barges
following EU standards for the
transport of food stuffs
C Low High 3 Transport of most of the vegetable oils
is by means of transport that is
dedicated to food stuffs.
The Food Hygiene
Regulation No. EC/852/2004
requires the transport of liquid
food stuffs by tank cars, rail
tanks and barges to be
dedicated to that of food
stuffs.
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use (Ref
Check previous cargoes via
FEDIOL practical guide to
previous cargo(es) for means
of transport and tank lining
(Ref 07COD143F).
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Feed Risk assessment of the chain of soya (bean) meal and oil products
07COD138).
- Tank coasters following EU
standards for the transport of
food stuffs
C Low High 3 Tank coasters carrying oils and fats
during short sea voyages in the EU
must have as an absolute minimum as
the immediate previous cargoes a
product that is either a foodstuff or a
product appearing on the EU list of
accepted immediate cargoes of
Directive 96/3/EC.
FEDIOL Code of Practice for
the transport in bulk of oils
and fats into or within the
European Union (Ref
14COD152) (including
FOSFA operational
procedures).
Check previous cargoes via
FEDIOL practical guide to
previous cargo(es) for means
of transport and tank lining
(Ref 07COD143F). FOSFA
certificate of compliance,
cleanliness and suitability of
Ship’s tanks issued by a
FOSFA Member
Superintendent. FOSFA
combined Masters certificate
signed by the Captain/First
Officer or an equivalent
statement signed by the ship’s
owner or authorised agent,
applicable before any loading
or cargo transfer.
Contamination by cleaning
agents
- Tank cars, rail tanks and
barges
C Medium Medium 3 Increased risk at cleaning stations that
clean both feed and chemical tanks on
one site.
FEDIOL Code of Practice for
the transport in bulk of oils
and fats into or within the
European Union (Ref
14COD152).
Apply good practices for
cleaning of tanks.
.
- Tank coasters C Medium Medium 3 Increased risk in case coaster is not
dedicated to feed- or foodstuff.
FEDIOL Code of Practice for
the transport in bulk of oils
and fats into or within the
European Union (Ref
14COD152) (including
FOSFA operational
FOSFA certificate of
compliance, cleanliness and
suitability of Ship’s tanks
issued by a FOSFA Member
Superintendent.
FOSFA combined Masters
EFISC Guide – Sector reference document on the manufacturing of safe feed materials from oilseed crushing and vegetable oil refining
73
Feed Risk assessment of the chain of soya (bean) meal and oil products
procedures). certificate signed by the
Captain/First Officer or an
equivalent statement signed
by the ship’s owner or
authorised agent, applicable
before any loading or cargo
transfer.
Heating or cooling fluids
from equipment
- Tank cars C Low High 3 Stainless steel tanks are used which
are heated with cooling water from the
motor through a system of double walls
(and not coils).
FEDIOL Code of Practice for
the transport in bulk of oils
and fats into or within the
European Union (14COD152).
Use of thermal heating fluids
in direct heating systems is
forbidden.
- Rail tanks, tank barges
- Tank coasters
C
C
Low
Low
High
High
3
3
Toxic thermal heating fluids may still be
used. However, due to the relatively
low heating temperatures applied
during transport, the chance of leakage
of thermal heating fluids into the
product is low.
Toxic thermal heating fluids may still be
used. However, due to the relatively
low heating temperatures applied
during transport, the chance of leakage
of thermal heating fluids into the
product is low.
FEDIOL Code of Practice for
the transport in bulk of oils
and fats into or within the
European Union (14COD152).
FEDIOL Code of Practice for
the transport in bulk of oils
and fats into or within the
European Union (14COD152)
(including FOSFA operational
procedures).
Heating coils of rail tanks
must be of stainless steel .
If thermal heating fluids have
been used, the transporter of
the oil must provide for
documentation on possible
net losses and analyse
accordingly if necessary.
If thermal heating fluids have
been used, the transporter of
the oil must provide for
documentation on possible
net losses and analyse
accordingly if necessary.
The use of hot water or steam
heating is recommended.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
Foreign bodies P Medium Medium 3 A quality plan should require
the loading of tank cars with
refined oils under a roof.
Adulteration C/P/B Medium Medium 3 Adulteration with mineral oils has
happened with the transport of oils in
the countries of origin of these oils.
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use (Ref
07COD138)
Analyse all incoming batches.
Application of minimum
mandatory requirements of
FEDIOL code of working
practice for bulk road and tank
container transport of fats and
oils for direct food use such
as availability of whereabouts
of the truck during the journey
and sealing of the tank (Ref
07COD138).
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Feed Risk assessment of the chain of soya (bean) meal and oil products
C. Storage of soybean oil
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY
STANDARDS AND/OR
CONTRACT TERMS
CONTROL MEASURE REMARKS
Contamination due to lack
of segregation
(contamination from previous
cargoes, use of incorrect
joining, shared equipment)
C Low High 3 This risk classification applies to terminals
that store both chemicals and vegetable
oils. Less risk is involved when the tank
terminal applies the EU list of acceptable
previous cargoes during sea transport to
the storage of vegetable oils. Least risk is
involved when the vegetable oils are
stored in tanks that are dedicated to the
storage of foodstuffs.
Terminals in the EU that store
oils and fats for food
application are obliged to
apply HACCP (EC Regulation
No. 852/2004)
Food or feed dedication of
storage tanks. Otherwise,
storage tanks must at least
adhere to the EU rules on
previous cargoes that have
been set up for sea transport
in Directive 96/3/EC.
Contamination by cleaning
agents
C Low High 3 This risk classification applies to terminals
that store both chemicals and vegetable
oils. They may abstain from using cleaning
agents that are suitable for use in the food
industry. For tank terminals in the EU that
apply HACCP and that keep the storage of
vegetable oils and chemicals separated,
the chance of using the wrong cleaning
agents is very low.
Cleaning agents must be
suitable for use in the food
industry.
Solvent from coating C Low High 3 Solvents from virgin coatings migrating to
the oil, which may end up in the fatty acid
distillates during refining
Use stainless steel tanks or in
case of use of tanks with
virgin coating, do not feed the
FAD
Thermal heating fluids from
failing equipment
C Low High 3 Toxic thermal heating fluids may still be
used. However, due to the relatively low
heating temperatures applied during
storage, the chance of leakage of thermal
heating fluids into the product is low.
If thermal heating fluids have
been used, the storage
company must provide for
documentation on net losses
and analyse accordingly, if
The use of water and
steam heating is
recommended.
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76
Feed Risk assessment of the chain of soya (bean) meal and oil products
necessary.
Misuse of additives C Low High 3 Additives allowed for food oil applied to oil
for feed –or vice versa- for which use they
may not have been approved.
Agree on clear specifications
as regards use of additives
Adulteration with mineral oil Low High 3 Adulteration with mineral oils has
happened in the countries of origin.
Control has been intensified and the
chance of adulteration taking place has
decreased.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
D. Transport of soybean oil by ocean going vessel
HAZARD CAT. CHANCE SERIOUSNESS RISK
CLASS. JUSTIFICATION
LEGISLATION, INDUSTRY STANDARDS
AND/OR CONTRACT TERMS CONTROL MEASURE REMARKS
Transport contamination
- Contamination by previous
cargoes present in tanks or
pipes
C Medium Medium 3 Ocean going vessels carrying oils and fats
for edible use into the EU must have as an
absolute minimum that the immediate
previous cargoes is a product that is either
a foodstuff or a product appearing on the
EU list of accepted immediate cargoes of
Directive 96/3/EC.
Directive 96/3/EC (Derogation to EC
Regulation No. 852/2004) requires that
previous loads have to be checked.
FOSFA contracts oblige the seller to
inform the buyer what the three
preceding cargoes have been during
the sea transport of oils and fats.
FEDIOL Code of Practice for the
transport in bulk of oils and fats into or
within the European Union (Ref
14COD152) (including FOSFA
operational procedures).
The EU has not regulated the sea
transport of oils and fats for feed
application.
FOSFA certificate of
compliance, cleanliness
and suitability of Ship’s
tanks issued by a FOSFA
Member Superintendent.
FOSFA combined Masters
certificate signed by the
Captain/First Officer or an
equivalent statement
signed by the ship’s owner
or authorised agent,
applicable before any
loading or cargo transfer
The use of dedicated pipe
lines at loading and
unloading.
- Contamination by cleaning
agents
C Low High 3 Usually maritime business sticks to good
practice.
Check ship log-book.
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Feed Risk assessment of the chain of soya (bean) meal and oil products
Solvent from coating C Low High 3 Solvents from virgin coatings migrating to
the oil, which may end up in the fatty acid
distillates during refining
Use stainless steel tanks
or in case of use of tanks
with virgin coating, do not
feed the FAD
Solvent from coating
Thermal heating fluids
(THF) from equipment
C Low High 3 Toxic thermal heating fluids may still be
used. However, due to the relatively low
heating temperatures applied during
transport, the chance of leakage of
thermal heating fluids into the product is
low.
FEDIOL Code of Practice for the
transport in bulk of oils and fats into or
within the European Union (including
FOSFA operational procedures).
If thermal heating fluids
have been used, the
transporter of the oil must
provide for documentation
on possible net losses and
analyse accordingly if
necessary.
The use of water and steam
heating is recommended.
Hydraulic oils from portable
pumps
C Low High 3 Hydraulic oils from portable pumps may
be toxic.
The use of portable pumps
with clear separation of
hydraulic motor from
pump. If not, hydraulic oils
of food grade quality must
be used.
Hydraulic motors that are
directly linked to the pump
allow for unwanted leakages
of hydraulic oil into the
vegetable oil in case of seal
failure.
Adulteration with mineral oil Low High 3 Adulteration with mineral oils has
happened in the countries of origin.
Control has been intensified and the
chance of adulteration taking place has
decreased.